Junior Clinical Research Associate Acquiring Certification Through Dc Solutions S.R.L.S
CurrentTherapeutic Area: Oncology, Cardiology, Neurology, Metabolic Diseases. Co-Visits Performed:• COV (Close Out Visit) - 16 April 2024 - (Interventional Clinical Trial)• COV (Close Out Visit) - 17 April 2024 - (Interventional Clinical Trial)• MV (Monitoring Visit) - 22 May 2024 - (Interventional Clinical Trial)• MV (Monitoring Visit) - 08 July 2024 - (Interventional Clinical Trial)• SIV (Site Initiation Visit) - 18 July 2024 - (Interventional Clinical… Show more Therapeutic Area: Oncology, Cardiology, Neurology, Metabolic Diseases. Co-Visits Performed:• COV (Close Out Visit) - 16 April 2024 - (Interventional Clinical Trial)• COV (Close Out Visit) - 17 April 2024 - (Interventional Clinical Trial)• MV (Monitoring Visit) - 22 May 2024 - (Interventional Clinical Trial)• MV (Monitoring Visit) - 08 July 2024 - (Interventional Clinical Trial)• SIV (Site Initiation Visit) - 18 July 2024 - (Interventional Clinical Trial)Education: • Clinical experimentation: methodology and legislation• GCP• GMP with specific reference to the drug in experimentation• Pharmacovigilance• Quality Assurance and Quality System• Regulatory Procedures• Monitoring ProceduresTraining on the job: • Preparation for visits: protocol review, confirmation letter, check confirmation letters• Site Initiation Visit (on-site/remote) : support CRAs in checking documents completeness, ensuring signatures filling, ISFs review• Monitoring Visits (on-site/remote) : support CRAs in Source Data Verification and Review, eCRF analysis, operation and validation, query resolution, drug accountability and logs completeness check• Close - out Visit (on-site/remote) : support CRAs in ISFs review, return and destruction's procedures of the IMP and of all unused FORMs • Reporting writing• Support CRAs in review and translation of critical documentation• Regulatory Procedures• Monitoring Procedures Show less